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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04008407




Registration number
NCT04008407
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019
Date last updated
24/07/2024

Titles & IDs
Public title
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
Scientific title
Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
Secondary ID [1] 0 0
AU RED HREC/17/WMEAD/497
Universal Trial Number (UTN)
Trial acronym
COVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasm 0 0
Endoscopic Mucosal Resection 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Submucosal Dissection
Treatment: Surgery - Endoscopic Mucosal Resection

Active comparator: ESD - Lesion with overt stigmata of SMIC or those with high risk (=\> 10%) for covert SMIC.

Active comparator: EMR - Lesion with no overt or a low risk for (\<10%) for covert SMIC


Treatment: Surgery: Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection (ESD) results in en-bloc resection of LSL, regardless of lesion size. This allows for accurate histopathological assessment of SMIC, R0/R1 resection and depth of invasion. ESD is considered a potentially curative for superficial cancers (T1a).

Treatment: Surgery: Endoscopic Mucosal Resection
EMR is the current standard for treating colonic LSL and has been validated to be safe and efficacious. LSLs =\> 20mm are frequently resected piecemeal. Recent research show that resection margin soft coagulation reduces recurrence rates to those similar to en-bloc resections.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of surgical referral
Timepoint [1] 0 0
3 months post procedure
Secondary outcome [1] 0 0
R0 resection rate
Timepoint [1] 0 0
3 months post procedure
Secondary outcome [2] 0 0
En Bloc resection rate
Timepoint [2] 0 0
3 months post procedure
Secondary outcome [3] 0 0
Technical success rate
Timepoint [3] 0 0
3 months post procedure
Secondary outcome [4] 0 0
Duration of procedure
Timepoint [4] 0 0
procedure
Secondary outcome [5] 0 0
Adenoma recurrence rate
Timepoint [5] 0 0
3 years post procedure

Eligibility
Key inclusion criteria
* All patients referred for colorectal resection of large laterally spreading lesions in colon.
* Can give informed consent to trial participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous resection or attempted resection of target adenoma lesion
* Endoscopic appearance of invasive malignancy
* Age less than 18 years
* Pregnancy
* Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
* Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines
* American Society of Anesthesiology (ASA) Grade IV-V

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
391
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Colonic Laterally spreading lesions (LSL) =\> 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V.

In a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.
Trial website
https://clinicaltrials.gov/study/NCT04008407
Trial related presentations / publications
Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
Iishi H, Tatsuta M, Iseki K, Narahara H, Uedo N, Sakai N, Ishikawa H, Otani T, Ishiguro S. Endoscopic piecemeal resection with submucosal saline injection of large sessile colorectal polyps. Gastrointest Endosc. 2000 Jun;51(6):697-700. doi: 10.1067/mge.2000.104652.
Risio M. The natural history of colorectal adenomas and early cancer. Pathologe. 2012 Nov;33 Suppl 2:206-10. doi: 10.1007/s00292-012-1640-6.
Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
Nanda KS, Tutticci N, Burgess NG, Sonson R, Williams SJ, Bourke MJ. Endoscopic mucosal resection of laterally spreading lesions involving the ileocecal valve: technique, risk factors for failure, and outcomes. Endoscopy. 2015 Aug;47(8):710-8. doi: 10.1055/s-0034-1391732. Epub 2015 Mar 12.
Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.
Lee EJ, Lee JB, Lee SH, Youk EG. Endoscopic treatment of large colorectal tumors: comparison of endoscopic mucosal resection, endoscopic mucosal resection-precutting, and endoscopic submucosal dissection. Surg Endosc. 2012 Aug;26(8):2220-30. doi: 10.1007/s00464-012-2164-0. Epub 2012 Jan 26.
Terasaki M, Tanaka S, Oka S, Nakadoi K, Takata S, Kanao H, Yoshida S, Chayama K. Clinical outcomes of endoscopic submucosal dissection and endoscopic mucosal resection for laterally spreading tumors larger than 20 mm. J Gastroenterol Hepatol. 2012 Apr;27(4):734-40. doi: 10.1111/j.1440-1746.2011.06977.x.
Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Bourke, Prof.
Address 0 0
Country 0 0
Phone 0 0
+61288905555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04008407